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Associate Director, Final Medical Signatory

5+ years
Not Disclosed
10 Nov. 24, 2024
Job Description
Job Type: Full Time Remote Education: MBBS/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

The job description is for a Medical Services Lead at Organon, responsible for overseeing medical communications, managing promotional material review processes, and responding to medical inquiries from healthcare providers and other stakeholders. Here's a breakdown of the position:

Position Overview:

The Medical Services Lead will manage the processes related to the review and approval of promotional materials, triage medical inquiries, and ensure that all responses align with company policies and local regulations.

Key Responsibilities:

  1. Medical Review:

    • Oversee all processes related to the review and approval of promotional materials (e.g., review workflows, priorities, and metrics).
    • Ensure compliance with local regulations and company policies in medical review processes before materials are publicly released.
    • Lead and provide training on compliance to the country staff.
  2. Medical Information:

    • Triage and respond to unsolicited on-label and off-label medical inquiries from healthcare providers and other stakeholders.
    • Develop standardized answers for frequently asked questions or routine requests in collaboration with Medical Advisors and Medical Science Liaisons.
    • Research and compile clinical support from published and unpublished literature, ensuring scientifically accurate, fair, and balanced communications.
    • Report adverse events and product quality complaints to the relevant departments.
  3. DPOC (Designated Point of Contact) Process Management:

    • Ensure accurate receipt, classification, and routing of product inquiries, meeting regulatory and business requirements.
    • Maintain the DPOC database and generate monthly performance metrics.
    • Identify gaps in the medical information process and provide solutions to improve efficiency.
    • Support and train staff, including Medical Advisors and Medical Science Liaisons, on the management of DPOC inquiries.

Education and Certifications:

  • Required:
    • GPhC registered pharmacist or GMC registered doctor
    • UK Final Medical Signatory

Competencies and Experience:

  • At least 5 years of experience in the pharmaceutical industry.
  • In-depth understanding of the ABPI code (Association of the British Pharmaceutical Industry).
  • Familiarity with SOPs and regulations governing promotional review, medical inquiry response, and DPOC processes.
  • Ability to analyze Key Performance Indicators (KPIs) regularly and identify and manage risks or issues.
  • Strong collaboration skills to work with commercial and medical affairs teams to ensure alignment and streamline the approval process.

Organon Overview:

  • Organon is a $6.5 billion global healthcare company that focuses on women’s health and is expanding its portfolio in unmet needs and biosimilars.
  • The company aims to provide innovative health solutions and improve health for women, families, and communities.
  • Organon is an equal opportunity employer, committed to creating an inclusive and diverse work environment.

Job Requirements:

  • Employee Status: Regular position
  • Travel: Some travel may be required
  • Relocation: No relocation assistance provided
  • Flexible Work Arrangements: Likely available depending on business needs
  • No VISA sponsorship offered for this role

This role offers an opportunity for an experienced professional to lead medical services and ensure compliance while contributing to the company's mission in advancing women’s health.